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Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

Primary Purpose

Gastroesophageal Reflux Disease, Healthy Volunteers

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: - Healthy volunteers must have less than one episode of reflux or dyspeptic symptoms per month of no more than mild severity in the last 3 months

- Reflux patients (GERD) must have chronic symptoms (>8 weeks) suggestive for GERD (definition and questionnaire see Appendix page 30). In addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). If in addition a pH-study has been performed the acid exposure must be > 4.2% / 24h.

Exclusion criteria: - Age under 18 or above 65

Pathologic underweight or overweight (BMI < 18 or > 30 kg/m2)
Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders)
Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse
Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs
Positive Helicobacter pylori status on 13C-Urea breath test
Presence of metallic implants, devices or metallic foreign bodies
Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study)
Female volunteers without adequate contraception for the duration of the study
Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion

Sites / Locations

University of Zurich

Outcomes

Primary Outcome Measures

To assess the volume of gastric secretion in GERD patients and healthy volunteers with and without acid suppression.

Secondary Outcome Measures

Full Information

NCT ID

NCT01212614

First Posted

September 29, 2010

Last Updated

September 11, 2012

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT01212614

Brief Title

Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

Official Title

A Study for Measurement of Gastric Secretion by Magnetic Resonance Imaging (MRI) Under Inhibition of Gastric Secretion by Proton Pump Inhibitors in Healthy Subjects and Patients With Reflux Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

5. Study Description

Brief Summary

This study bases on the successfully completed project SNF 320000-112006 (EK 1152 and SwissMedic 2005dr2207e) and will document the physiological effects of inhibited gastric secretion on the volume as well as the acidity of gastric secretion by high dose proton pump inhibitors in GERD patients and healthy controls. Twelve participants in each group will be studied in a randomized, double-blind placebo controlled trial. A novel non-invasive MRI technique developed in Zurich will assess the volume of gastric secretion following the ingestion of a regular liquid meal. In addition, intragastric / esophageal pH monitoring will assess the link between volume and intragastric distribution of gastric secretion on reflux events and symptoms. In addition, the effect of gastric secretion on outcome parameters of a non-invasive stable isotope breath test for measurement of gastric emptying will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease, Healthy Volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring

Intervention Description

MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring

Primary Outcome Measure Information:

Title

To assess the volume of gastric secretion in GERD patients and healthy volunteers with and without acid suppression.

Time Frame

October 2010 - October 2012

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: - Healthy volunteers must have less than one episode of reflux or dyspeptic symptoms per month of no more than mild severity in the last 3 months - Reflux patients (GERD) must have chronic symptoms (>8 weeks) suggestive for GERD (definition and questionnaire see Appendix page 30). In addition, the initial screening manometry must show no severe esophageal dysmotility (e.g. spasm, achalasia). If in addition a pH-study has been performed the acid exposure must be > 4.2% / 24h. Exclusion criteria: - Age under 18 or above 65 Pathologic underweight or overweight (BMI < 18 or > 30 kg/m2) Previous history of gastrointestinal disease or surgery (excludes appendectomy, cholecystectomy, hernia repair and anorectal disorders) Previous cardiorespiratory (excludes arterial hypertension), hematologic, renal, atopic, alimentary or psychiatric disease, diabetes, drug or alcohol abuse Patient unable to stop medication that alters gut function for 72 hours prior to the study, including anticholinergics, prokinetics, proton-pump inhibitors, non-steroidal anti-inflammatory drugs Positive Helicobacter pylori status on 13C-Urea breath test Presence of metallic implants, devices or metallic foreign bodies Pregnancy and lactation (female patients of child bearing age will receive a pregnancy test prior to study) Female volunteers without adequate contraception for the duration of the study Involvement in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Werner Schwizer, Professor MD

Organizational Affiliation

University Hospital Zurich, Gastroenterology and Hepatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

26328588

Citation

Steingoetter A, Sauter M, Curcic J, Liu D, Menne D, Fried M, Fox M, Schwizer W. Volume, distribution and acidity of gastric secretion on and off proton pump inhibitor treatment: a randomized double-blind controlled study in patients with gastro-esophageal reflux disease (GERD) and healthy subjects. BMC Gastroenterol. 2015 Sep 2;15:111. doi: 10.1186/s12876-015-0343-x.

Results Reference

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Measurement of Gastric Secretion by MRI Under Inhibition by ProtonPump Inhibitors in Healthy Subjects & in GERD Patients

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